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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03059823




Registration number
NCT03059823
Ethics application status
Date submitted
9/02/2017
Date registered
23/02/2017
Date last updated
13/12/2023

Titles & IDs
Public title
A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors
Scientific title
A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of INCMGA00012 in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
INCMGA 0012-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Advanced Solid Tumors 0 0
Metastatic Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - retifanlimab

Experimental: Dose Escalation-Q2W - INCMGA00012 treatment once every 2 weeks.

Experimental: Dose Escalation- Q3W - INCMGA00012 treatment once every 3 weeks.

Experimental: Dose Escalation- Q4W - INCMGA00012 treatment once every 4 weeks.

Experimental: Expansion Cohort - INCMGA00012 treatment for locally advanced or metastatic solid tumors.


Treatment: Drugs: retifanlimab
Anti-PD-1 monoclonal antibody
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03
Timepoint [1] 0 0
24 months
Primary outcome [2] 0 0
MTD
Timepoint [2] 0 0
24 months
Secondary outcome [1] 0 0
AUC
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Cmax
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
Tmax
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Ctrough
Timepoint [4] 0 0
24 months
Secondary outcome [5] 0 0
Total body clearance of the drug from plasma (CL) of INCMGA00012
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
Vss
Timepoint [6] 0 0
24 months
Secondary outcome [7] 0 0
t1/2
Timepoint [7] 0 0
24 months
Secondary outcome [8] 0 0
ADA
Timepoint [8] 0 0
24 months

Eligibility
Key inclusion criteria
Histologically proven, locally advanced unresectable or metastatic solid tumors for whom no
approved therapy with demonstrated clinical benefit is available or standard treatment was
declined. Patients enrolled to Cohort H (endometrial cancer 500 mg Q4W) must have MSI-H or
dMMR endometrial cancer, as determined by a local laboratory using IHC or PCR methods and
must also have tissue (fresh or archival) available for central confirmation of diagnosis

- Expansion cohort(s): Progression during or following at least 1, and up to 5, previous
systemic therapies, consistent with the standard of care for the specific tumor type.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Life expectancy = 12 weeks

- Measurable disease

- Acceptable laboratory parameters
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Symptomatic central nervous system (CNS) metastases.

- For Cohort Expansion, patients who have previously received an immune checkpoint
inhibitor (e.g., anti-PD-L1, anti-PD-1, anti-CTLA-4) are not eligible for this study.

- Patients with any history of known or suspected autoimmune disease with the specific
exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring
systemic treatment (within the past 2 years), and patients with a history of Grave's
disease that are now euthyroid clinically and by laboratory testing.

- Treatment with any systemic anti-neoplastic therapy, or investigational therapy within
the 4 weeks prior to the initiation of study drug administration.

- Treatment with radiation therapy within 2 weeks prior to the initiation of study drug
administration.

- Clinically significant cardiovascular disease

- Clinically significant pulmonary compromise, including a requirement for supplemental
oxygen use to maintain adequate oxygenation.

- Presence of active pneumonitis or history of non-infectious pneumonitis.

- Clinically significant gastrointestinal disorders

- Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral
treatment within 7 days prior to the initiation of study drug. Patients requiring any
systemic antiviral, antifungal, or antibacterial therapy for active infection must
have completed treatment no less than one week prior to the initiation of study drug

- Known history of positive testing for human immunodeficiency virus or history of
acquired immune deficiency syndrome.

- Known history of hepatitis B or hepatitis C infection or known positive test for
hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain
reaction (PCR)

- Vaccination with any live virus vaccine within 4 weeks prior to the initiation of
study drug administration. Inactivated annual influenza vaccination is allowed

- Dementia or altered mental status that would preclude understanding and rendering of
informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/11/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/04/2024
Actual
Sample size
Target
Accrual to date
Final
325
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Chris Obrien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
St Vincent'S Hospital Sydney - Darlinghurst
Recruitment postcode(s) [1] 0 0
02050 - Camperdown
Recruitment postcode(s) [2] 0 0
02010 - Darlinghurst
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
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New Jersey
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United States of America
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North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia
Country [7] 0 0
Belgium
State/province [7] 0 0
Leuven
Country [8] 0 0
Belgium
State/province [8] 0 0
Liege
Country [9] 0 0
Bulgaria
State/province [9] 0 0
Burgas
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Sofia
Country [11] 0 0
China
State/province [11] 0 0
Beijing
Country [12] 0 0
China
State/province [12] 0 0
Changsha
Country [13] 0 0
China
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Guangzhou
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China
State/province [14] 0 0
Jinan
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China
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Kunming
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China
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Nanjing
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China
State/province [17] 0 0
Shijiazhuang
Country [18] 0 0
China
State/province [18] 0 0
Taiyuan
Country [19] 0 0
China
State/province [19] 0 0
Wuhan
Country [20] 0 0
China
State/province [20] 0 0
Xi'an
Country [21] 0 0
China
State/province [21] 0 0
Xiamen
Country [22] 0 0
China
State/province [22] 0 0
Zhengzhou
Country [23] 0 0
Finland
State/province [23] 0 0
Helsinki
Country [24] 0 0
Finland
State/province [24] 0 0
Turku
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France
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Bordeaux
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France
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Lyon
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France
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Nice
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France
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Paris
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France
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Saint-herblain
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France
State/province [30] 0 0
Toulouse
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France
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Villejuif
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Germany
State/province [32] 0 0
Berlin
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Germany
State/province [33] 0 0
Dresden
Country [34] 0 0
Germany
State/province [34] 0 0
Essen
Country [35] 0 0
Germany
State/province [35] 0 0
Freiburg
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Germany
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Munchen
Country [37] 0 0
Germany
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Munich
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Italy
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Ancona
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Italy
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Candiolo
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Italy
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Naples
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Italy
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Rome
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Latvia
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Riga
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Lithuania
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Vilnius
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New Zealand
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Auckland
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New Zealand
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Wellington
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Poland
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Gdynia
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Poland
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Krakow
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Poland
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Lublin
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Poland
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Olsztyn
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Poland
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Otwock
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Poland
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Poznan
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Poland
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Warsaw
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Spain
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Barcelona
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Spain
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Madrid
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Ukraine
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Dnipro
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Ukraine
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Ivano-frankivsk
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Ukraine
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Sumy
Country [58] 0 0
Ukraine
State/province [58] 0 0
Uzhgorod
Country [59] 0 0
Ukraine
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Vinnytsia
Country [60] 0 0
United Kingdom
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London
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United Kingdom
State/province [61] 0 0
Manchester
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Incyte Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary goal of this Phase 1 study is to characterize the safety and tolerability of
INCMGA00012 and establish the maximum tolerated dose (MTD) of INCMGA00012 administered on
either every two week or every four week schedules of administration among patients with
solid tumors. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of INCMGA00012
will also be assessed.

The purpose of Amendment 5 is to obtain additional safety experience at the newly defined
recommended Phase 2 dose of 500 mg every 4 weeks in patients with endometrial cancer,
specifically either microsatellite instability-high (MSI-H) or mismatch repair deficient
(dMMR). Additionally, every 3 week (Q3W) flat-dosing will be studied in an additional tumor
agnostic cohort.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03059823
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Incyte Medical Monitor
Address 0 0
Incyte Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03059823